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Home » Topics » Regulatory » Policy

Policy
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Pills arranged in dollar sign

US threat of most-favored-nation Rx pricing intensifies

May 15, 2025
By Mari Serebrov
No Comments
Recognizing the potential legal challenges to U.S. President Donald Trump’s executive order calling for most-favored-nation (MFN) prescription drug pricing and the limits of that order, several congressional Democrats introduced a bill in both the House and Senate May 14 that could make MFN pricing the law of the land and extend it to both government health programs and private insurance.
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Speech bubbles

HHS asks for input on which regs to kill

May 13, 2025
By Mari Serebrov
No Comments
As the U.S. Department of Health and Human Services (HHS) and its agencies begin weeding out old regulations, the department is requesting public input to help identify and eliminate outdated or unnecessary regulations.
Read More
Jorge A. Goldstein at Bio Korea 2025
Bio Korea 2025

US legal issues to track in pharma, biotech

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
Read More
Illustration of Won currency, graph, up arrows

Korea pharma stocks rally; Celltrion welcomes US drug pricing

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.
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Drug capsule and dollar sign

Little bite from voluntary most-favored nation Rx pricing order

May 12, 2025
By Mari Serebrov
No Comments
After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite, as one analyst put it. Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, said the EO is unlikely to rattle the biopharma sector, even though it lacked the certainty to completely remove the MFN overhang. “We see reason for relief and, alongside improving FDA clarity and limited tariff risk, expect biopharma to be viewed as increasingly investable,” Abrahams said.
Read More
Global market charts

Pause on tariffs could boost med-tech earnings

May 12, 2025
By Annette Boyle
The long-term status of the trade dispute with China remains unclear, but a 90-day reduction in stratospheric tariffs imposed by the U.S. and China on their respective products provides breathing room for the med-tech companies predicting the hardest hit from the original levels.
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Astrazeneca production and manufacture facility

FDA to conduct unannounced inspections at OUS sites

May 9, 2025
By Mark McCarty
The U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard.
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Digital globe illustrating pharma trade, tariffs

Navigating the Trump tariffs, part two: Amgen, Biogen, others

May 9, 2025
By BioWorld staff
No Comments
As biopharma companies continue to roll out their first-quarter  earnings, Trump administration tariffs remain at the top of investors’ minds. While executives offer their various strategies to appease concerns, the uncertainty prevails, making it difficult to clearly satisfy all of the questions.
Read More
Jorge A. Goldstein at Bio Korea 2025

US legal issues to track in pharma, biotech: Bio Korea 2025

May 8, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
Read More
Microscope and coronavirus illustration

US-funded gain-of-function research paused for stiffer oversight

May 7, 2025
By Mari Serebrov
No Comments
In a throwback to the Obama administration, U.S. President Donald Trump signed an executive order pausing federally funded research using infectious pathogens and toxins that may pose a danger until a safer, more enforceable and transparent policy governing such research can be developed and implemented.
Read More
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